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FDA 510(k)

LigaPASS

K-Number: K173506 · 2018-04-03

ApplicantMedicrea International SA
Decision Date2018-04-03
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LigaPASS is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K173506. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LigaPASS?

LigaPASS is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Medicrea International SA. The 510(k) number is K173506.

When did LigaPASS receive FDA 510(k) clearance?

LigaPASS received FDA 510(k) clearance on 2018-04-03, under 510(k) number K173506.

Who is the listed applicant for LigaPASS?

The FDA 510(k) record lists Medicrea International SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LigaPASS?

The FDA product code for LigaPASS is OWI.

Other records listing Medicrea International SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213659LigaPASS™ 2.0 Ligament Augmentation SystemK220810Infinity™ OCT System and PASS OCT Spinal SystemK220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemK212005UNiD Spine AnalyzerK213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemK210470C-CURVE Interbody Fusion Device

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Related Devices (Code: OWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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